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DIA 2021 Global Annual Meeting

COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and The Danish Medicines Agency’s Approaches

Session Chair(s)

Jesper Kjær, MS

Jesper Kjær, MS

  • Co-Chair, EMA/HMA Big Data Steering Group; Director of Data Analytics Centre
  • Danish Medicines Agency (DKMA), Denmark
This session will include presentations of the Danish Medicines Agency's COVID-19 cohort data analyses, the FDA’s N3C Data Enclave and the vaccine surveillance on COVID-19 patients using real-world data (RWD) from registries as examples of regulatory use of RWD during the COVID-19 pandemic.
Learning Objective : Describe the novel use of real-world data (RWD) during the COVID-19 pandemic; Describe, discuss, and evaluate the different opportunities and challenges in use of RWD given different healthcare settings and access to healthcare data.

Speaker(s)

Stine Hasling Mogensen, MPharm

DAC COVID: Exemplified by the Most Recent Analysis on Post-Acute Effects of Covid 19

Stine Hasling Mogensen, MPharm

  • Senior Scientific Advisor
  • Danish Medicines Agency, Denmark
Anton Pottegaard, DrSc, PhD, MPharm

Arterial Events, Venous Thromboembolism, Thrombocytopenia, and Bleeding After Vaccination in Denmark and Norway: Population-Based Cohort Study

Anton Pottegaard, DrSc, PhD, MPharm

  • Head of Research at the Hospital Pharmacy; Professor
  • University of Southern Denmark, Denmark
Mona Vestergaard Laursen, MPharm

Off-Label Use Monitoring Through Danish Registries

Mona Vestergaard Laursen, MPharm

  • Senior Advisor, Data Analytics Centre
  • Danish Medicines Agency, Denmark
Mitra Rocca, MSc

FDA Real-World Evidence Activities Related to Covid19

Mitra Rocca, MSc

  • Associate Director, Medical Informatics, Office of Translational Science, CDER
  • FDA, United States
Richard Forshee, PhD

COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and Their Novel Approach to Rapid Safety Surveillance

Richard Forshee, PhD

  • Deputy Director, OBPV CBER
  • FDA, United States